Regulatory Information
OTC Panel Submissions (Indices Only): 04 - Cough-Cold
CCABA Submission Chart
Volume Number |
Submittor |
Subject |
|---|---|---|
|
040001 to 040004 |
Merck Chem. Division Thomas Davis |
Noscapine |
| 040005 | Chesebrough-Ponds | Pertussin |
|
040006 to 040009 |
McNeil Laboratories Patrick H. Seay, Ph.D. |
Co-Tylenol Cold Formula Tablets |
| 040010 | Monsanto | Methapyrilene Hcl |
| 040011 | Creomulsion Co. | Creomulsion |
|
040012 to 040018 |
Pennwalt | Allerest |
| 040019 | Smith Kline & French | Ornex |
|
040020 to 040021 |
Smith Kline & French | Benzedrex |
| 040021 | Smith Kline & French | Ornacol |
| 040022 | Ludens | Cough Drops |
|
040023 to 040025 |
Calgon Consumer Products Jane Howell |
Sucrets |
| 040026 |
A.H. Robins Co. Robitussin |
Glyceryl guaiacolate |
| 040027 | Pennwalt | Sinarest Tablets |
| 040028 | ||
|
040029 to 040046 |
Johnson & Johnson | Sine-aid |
| 040032 | USV Pharmaceutical Corp. | Liquiprin |
|
040047 to 040055 |
Vicks Chemical Co. | Nyquil Nighttime Cold Medicine |
|
040056 to 040060 040060A |
Vicks Chemical Co. | Vicks Vapor Rub |
|
040061 to 040063 |
Vicks Chemical Co. | Vicks Cough Drop |
| 040063 | USV Pharmaceutical Corp. | Vaponefrin/Asthmanefrin |
| 040064 | Vicks Chemical Co. | Vicks Cough Syrup |
|
040065 to 040066 |
Vicks Chemical Co. | Vick Inhaler |
| 040067 | Vicks Chemical Co. |
Vick Cough Silencer Formula 44D Cough Syrup |
| 040068 | Vicks Chemical Co. | Formula 44D Cough Syrup |
|
040069 to 040070 |
Vicks Chemical Co. | Sinex Nasal Spray |
|
040071 to 040072 |
Vicks Chemical Co. | Formula 44D Cough Discs |
|
040073 to 040079 |
Vicks Chemical Co. | Formula 44 Cough Mixture |
| 040080 |
Father John Medicine Gerald Donehue |
Cough Syrup |
|
040081 to 040083 |
Schering Corp. Ken Brilhart |
Coricidin Chlor-Trimeton Afrin |
| 040084 | Hoffman-LaRoche | Romilar Syrup |
| 040085 | Hoffman-LaRoche | Romilar Expectorant |
| 040086 | Hoffman-LaRoche | Romilar HB Tablets |
| 040087 | Hoffman-LaRoche | Romilar CF Syrup |
| 040088 | Hoffman-LaRoche | Romilar CF Capsules |
| 040089 | Hoffman-LaRoche | Romilar Cough and Cold Capsules |
| 040090 | Hoffman-LaRoche | Children’s Romilar Syrup |
| 040091 | Hoffman-LaRoche | Romilar CF 8-Hr. Syrup |
| 040092 | Hoffman-LaRoche | Romilar Cough Discs |
| 040093 | Hoffman- LaRoche | Romilar Chewable Cough Tablets |
| 040094 | Hoffman-LaRoche | Romilar III |
| 040095 | Chesebrough-Ponds | Pertussin Wild Berry Cough Syrup |
| 040096 | Chesebrough-Ponds | Pertussin Medicated Vaporizer |
| 040097 | Chesebrough-Ponds | Pertussin Plus Nighttime Cold Medicine |
| 040098 | Knoll Pharm. Co. | Verequad |
| 040099 | USV Pharmaceutical Corp. | Arrestin |
| 040100 | USV Pharmaceutical Corp. | Vaponefrin/Asthmanefrin |
| 040102 | Abbott Laboratories | Quelidrine Cough Syrup |
| 040103 | Abbott Laboratories | Calcidrine Syrup |
| 040104 | A.H. Robins Co. | Robitussets Troches |
| 040105 | A.H. Robins Co. | Robitussin PE Syrup |
| 040106 | A.H. Robins Co. | Robitussin DM Syrup |
| 040107 | Ciba-Geigy Corp. | Otrivin Nasel Solution and Spray |
| 040108 |
LaWall & Harrison Donald Abbott |
Troutman’s Cough Syrup |
| 040109 | The Dow Chemical Co. | 2/G |
| 040110 | The Dow Chemical Co. | Novahistine-Elixir |
| 040111 | The Dow Chemical Co. | Novahistine |
| 040112 | The Dow Chemical Co. | 2 G/DM |
| 040113 | The Dow Chemical Co. | Novahistine Expectorant |
| 040114 | The Dow Chemical Co. | Novahistine - Special Study Addendum |
| 040115 | The Dow Chemical Co. | Novahistine Fortia |
| 040116 | Ives Labs. Inc. | Cerose DM |
| 040117 | Ives Labs. Inc. | Cerose |
| 040118 | The Mentholatum Co. | Mentholatum Ointment |
| 040119 | Whitehall Labs. Inc. | Dondrill Anticough Tablets |
| 040120 | Whitehall Labs. Inc. | Dristan Capsules |
| 040121 | Whitehall Labs. Inc. | Primatene Asthma Tablets (P) |
| 040122 | Whitehall Labs. Inc. | Primatene Asthma Tablets (M) |
| 040123 | Whitehall Labs. Inc. | Dristan Nasal Mist and Vapor Spray |
| 040124 | Whitehall Labs. Inc. | Clear and dry Tablets |
| 040125 | Whitehall Labs. Inc. | Dristan Cough Formula Liquid |
| 040126 | Whitehall Labs. Inc. | Dristan Decongestant Tablets |
| 040127 | Whitehall labs. Inc. | Primetime and Bronitin Mist |
| 040128 | Whitehall labs. Inc. | Bronitin Tablets |
| 040129 | Ives Labs. Inc. | Cerose Compond |
| 040130 | Ives Labs. Inc. | Cetro-Cirose |
| 040131 | Warner-Lambert Co. | Listerine Cough Control Lozenge |
| 040132 | Warner-Lambert Co. | Super Anahist Decongestant Nasal Spray |
| 040133 | Warner-Lambert Co. | Big 4 Cough Formula |
| 040134 | Warner-Lambert Co. | Listerine Antiseptic Lozenge |
| 040135 | Warner-Lambert Co. | Smith Brothers Cough Discs |
| 040136 | Warner-Lambert Co. | Hall’s Cough Tablets |
| 040137 | Warner-Lambert Co. | Listerine Cold Tablets |
| 040138 | Warner-Lambert Co. | Super Anahist Decongestant Tablets |
| 040139 | Ciba-Geigy | Privine Nasal Solution and Spray |
| 040140 | The Dow Chemical Co. | Novahistine Melet |
| 040141 | Plough, Inc. | St. Joseph ’s Cough Syrup for Children |
|
040142 to 040146 |
Merck/Calgon Consumer Products | Sucrets Cold Decongestant Formula |
| 040147 | Dorsey Laboratories | Dorcol Pediatric Cough Syrup |
| 040148 | Dorsey Laboratories | Dor-C Tablets |
| 040149 | Dorsey Laboratories | Chexit Tablets |
| 040150 | Dorsey Laboratories | Triaminic Expectorant |
| 040151 | Dorsey Laboratories | Triaminic Syrup |
| 040152 | Dorsey Laboratories | Triaminicin Nasal Spray |
| 040153 | Dorsey Laboratories | Triaminicin Tablets |
| 040154 | Dorsey Laboratories | Triaminicol Cough Syrup |
| 040155 | Dorsey Laboratories | TussagesicR Tablets and Suspension |
| 040156 | Dorsey Laboratories | Ursinus Inlay Tabs |
| 040157 | Merck Sharp & Dohme | Capsules & Elixer Propadrine |
| 040158 | Merck Sharp & Dohme | Capsules & Elixer Propadrine |
| 040159 | Sterling Drug, Inc. | Deka Cough Syrup |
| 040160 | Sterling Drug, Inc. | Neo-Synephrine Elixir |
| 040161 | Sterling Drug, Inc. | Breacol Cough Medicine |
| 040162 | Sterling Drug, Inc. | Bronkaid Mist |
| 040163 | Sterling Drug, Inc. | Breacol with Prylon Cough Medicine |
| 040164 | Sterling Drug, Inc. | Synephicol Cough Syrup |
| 040165 | Sterling Drug, Inc. | Recindal Cough Medicine |
| 040166 | Sterling Drug, Inc. |
Bronkotabs Bronkotabs HAFS Bronkolixer Bronkaid Tabs |
| 040167 | Sterling Drug, Inc. | NTR, NTZ, NRT Nose Drops and Nasal Spray |
| 040168 | Sterling Drug, Inc. | Neo-Synephrine Nose Drops & Nasal Spray |
| 040169 | Sterling Drug, Inc. |
Neo-Synephrine Asafen Synephricol |
| 040170 | FDA Library | Bibliography |
| 040171 | Chesebrough-Ponds | Pertussin Cold-Team-24 |
| 040172 | Norwich Pharmacal Co. | Quadrin |
| 040173 | Norwich Pharmacal Co. | Elixir Terpin Hydrate |
| 040174 | Norwich Pharmacal Co. | Baby Cough Syrup |
| 040175 | Searle Laboratories | Amodrine |
| 040176 | Pfizer Inc. | Coryban-D Nasal Spray |
| 040177 | Pfizer Inc. | Coryban-D Cough Syrup |
|
040178 to 040189 |
Pfizer Inc. | Coryban-D Cold Capsules |
| 040190 | The UpJohn Co. |
Cheracol, Cheracol D Cheracol Bilingual |
| 040191 | The UpJohn Co. | Orthoxicol (Orthoxine Cough Syrup) |
|
040192 to 040193 |
Miles labs. | Alka Seltzer |
|
040194 to 040197 |
A.H. robins Co. |
Dimetane Elixir (Brompheniramine) |
| 040198 | The UpJohn Co. | Pyrroxate Cap. And Tablets |
|
040199 to 040200 |
Warner-Chilcott |
Tedral Tedral Anti-H Tedral susp. |
| 040201 | UpJohn Co. | Emeracol |
| 040202 | UpJohn Co. | Terpin Hydrate and Codeine Elixir |
| 040203 | Block Drug Co. | BC All Clear |
| 040204 |
Key Pharm. Inc. M. Friedland |
Key Tusscapine |
| 040205 |
Sandoz Pharmaceuticals Div. Of Sandoz-Wander |
Fiogesic Tablets |
| 040206 | R. Schiffman Co. | Astmandor |
| 040207 | LaMay’s Asthmaeze, Inc. | LaMay’s Asthmaeze |
| 040208 | F & F Laboratories, Inc. | F & F Cough Lozenge |
| 040209 | E.R. Squibb & Sons, Inc. | Spec-T Lozenges |
| 040210 | Reid Provident Labs. | Reidacol Histelet Syrup, Histalet DM Syrup, PV tussin, Tusstrol, tusotrol DM, Coton Syrup |
| 040211 | Templetons Incorp. | RAZ-MAH Greys Capsules |
| 040212 | Holford Co. | Holfords Inhaler, Indian Chief Inhaler |
| 040213 | FDA | Summary of Submissions |
| 040214 | ||
| 040215 |
Colgate-Palmolive Co. C.H. Costello |
Congestaid RM Vaporizer |
| 040216 | ||
| 040217 | Penick | Glyceryl Guaiacolate |
| 040218 | Henry Thayer Co. | Thayers Slippery Elm Throat Lozenges |
| 040219 | UpJohn Co. | Hydriodic Acid |
| 040220 | UpJohn Co. | Iodized Lime |
| 040221 | UpJohn Co. | Special Formula #2 |
| 040222 |
UpJohn Co. J.A. Jacob, M.D. |
Cedicol (Cough Syrup), Orange |
|
040223 to 040224 |
Parke Davis & Co. | Benylin |
| 040225 | Federal Register 18471 | Revocation of Codeine Rx exemption |
| 040226 | Nat’l Analysts Inc. | Summary of Health Practices |
| 040227 | Parke-Davis | Benylin Expectorant |
| 040228 | Schering Co. | Afrin Supplement |
| 040229 | E.R. Squibb & Sons Inc. |
Spect-T Throat Spray Spec-T Anesthetic Lozenge |
| 040230 | Sterling Drug, Co. | Addition to Neo-Snyephrine |
| 040231 | Vicks Chemical Co. | Inhaler |
| 040232 | Schering/Amendment | Chlor-Trimeton |
| 040433 | Smith Kline & French | Clorpheniramine |
| 040434 | Smith Kline & French | Phenylpropanolamine |
| 040235 |
Creomulsion Co. V.O. Rankin |
Beechwood Creosote |
| 040236 | Lilly Research Labs. | Published articles re: Histadyl, methapyriline hydrochloride |
| 040237 | Chesebrough-Ponds | Additional information on Pertussin Med. Vapor |
| 040238 | Bristol-Myers | Safety of Sympathomimetic Drugs in Children 3-6 years |
| 040239 |
Smith Kline & French Cheston Simmons |
Caramiphen Edisylate |
| 040240 | Pfizer Pharmaceuticals | Toclase Syrup |
| 040241 |
Pfizer Pharmaceuticals Michael A. Hospador |
Toclase Tablets |
| 040242 |
Menley & James Labs. Thomas W. Richards |
Contac |
| 040243 |
E.R. Squibb & Sons Charles L. Kroll |
Spec-T Anesthetic Lozenges (New Formula-Revised) |
| 040244 |
Warner/Chilcott Chris P. Katsampes, M.D. |
Tedral |
| 040245 |
Smith Kline & French Cheston Simmons |
Ornacol Liquid and Capsules |
| 040246 |
Sterling Drug, Inc. B.G. Crouch, Ph.D. |
Thenfadil |
| 040247 |
Chesebrough-Ponds Murry Berdick, Ph.D. |
Pertussin Wild Berry Cough Syrup |
| 040248 |
Merck Sharp & Dohme M. Jane Howell, M.D. |
Sucrets |
| 040249 |
Merck Sharp & Dohme M. Jane Howell, M.D. |
Sucrets |
| 040250 | Bristol-Myers Co. | Nasel Decongestant Properties of Phenylpropanolamine |
| 040251 |
Vick Division Research Bob West, Ph.D. |
Concomitancy of Colds Symptoms |
| 040251A |
Vick Division Research Bob West, Ph.D. |
Patient Reports |
| 040252 | Vick Division Research | Topical Ephedrine |
| 040253 |
Smith Kline & French Cheston Simmons |
Benzedrex Inhaler Study |
| 040254 | Sterling Drug, Inc. | Breacol |
| 040255 |
Vick Division Research Bob West, Ph.D. |
Supplemental - Formula 44 |
| 040256 | UpJohn Co. | Bronchodilators in Cough |
| 040257 |
Vick Division Research Bob West, Ph.D. |
Vicks Cough Drops |
| 040258 |
Chattem Drug & Chem. Co. J.M. Holbert, Ph.D. |
Theophylline sodium glycinate |
| 040259 | Smith Kline & French | Caramiphen Edisylate |
|
040260 to 040263 |
Wyeth Labs. Wm. L. Langeland |
Phenergan |
| 040264 |
Vick Chemical Co. Bob West, Ph.D. |
Doxylamine (Decapryn) as an Antihistamine |
| 040265 |
Parke-Davis L.M. Lueck |
Proposed study plan for Diphenhydramine Hydrochloride Pseudoephedrine Hydro. |
|
040266 to 040271 |
Vicks Division Research John B. Ward |
Vaposteam |
| 040272 |
Smith Kline & French Cheston Simmon |
Propylhexedrine |
| 040273 |
Miles Labs. Alfred S. Neely, IV |
Phenylpropanolamine |
| 040274 |
Richardson-Merrell George Hoffnagle, M.D. |
Doxylamine Succinate |
| 040275 |
A.H. Robins F.A. Clark, Jr. |
Robitussin |
| 040276 |
UpJohn Co. Jay A. Nadel, M.D. |
The Role of Bronchodilators in CCABA Products |
|
040277 to 040278 |
Warner-Lambert Co. Richard C. Brogle |
Safety and Efficacy Review of OTC CCABA Products, Listerine Antiseptic |
| 040279 | Vick/Richardson Merrell | Oil of Turpentine |
| 040280 |
A.H. Robins F.A. Clark |
Suppl. Subm. To Clinical report of GG Robitussin |
|
040281 to 040283 |
Hoffman-LaRoche David Winer |
Phenindomine tartrate (Thephorin - Roche) |
| 040284 |
Ciba-Geigy Edward C. McKeen, M.D. |
Otrivin (xylometazoline) (hydrochloride NF) Nasal Solution and Spray |
| 040285 |
Miles Labs. Richard Shupack |
Three Clinical Salts of Phenylpropanolamine |
| 040286 |
Wyeth Labs. Dr. D. Shaw |
Antihistaminic Effectiveness of Promethazine |
| 040287 | Proprietary Association | Supplemental Data on Combinations on the Market |
| 040287A | Proprietary Association | Data on Combinations on the Market |
|
040288A 040288B |
Whitehall Labs. Swenson/Behrman |
Phenylephrine and Phenindamine |
| 040289 |
Creomulsion Company V.O. Rankin |
Creomulsion Cough Medicine |
| 040290 | Vicks Division Research | Ephedrine as Intranasal Decongestant |
| 040291 |
Vicks Division Research G. F. Hoffnagle |
Literature on Xylometazoline |
| 040292 |
Smith Kline & french Arthur L. Davis |
Cold, Cough, Allergy Bronchodilator & Anti-asthmatic Drugs |
| 040293 |
Pennwalt Corp. A. Lee Caldwell |
Nonprescription drugs Timed Release dosage forms |
| 040294 |
Smith Kline & French Phiip Tannebaum |
Caramiphene dislyate dosage Propylhexedrine Category I combinations |
| 040295 |
Vick Division Reasearch G. F. Hoffnagle |
Alcohol Vicks NYQUIL |
| 040296 |
Vick Division Research G. F. Hoffnagle |
Combinations approval Vicks Nyquil |
| 040297 |
Vick Division Research G. F. Hoffmangle |
Antitussive with Antihistamine Vicks Formula 44 Cough Mixture |
| 040298 | OTC Volume for References | Unpublished data, Memos and Letters |
|
040299A 040299B |
Parke-Davis | Presentation on Benylin |
| 040300 | Bristol-Myers | Concerning Combo. Policy |
| 040301 | Wyeth Labs./AMHO | Concomitance of Symptoms: Rhinorrhea & Cough |
| 040302 | Hoffman-LaRoche | Activity of Commercial Anthistamines by an In Vivo Evaluation Method |
| 040303 | Proprietary Association | Antihistamine Animal Tests |
| 040304 | Health Research Group | Combo. Policy |
| 040305 | Pennwalt Corp. | Presentation regarding Timed Release Dosage Forms |
|
040306 to 040315 |
Vick/Richardson Merrell | Supplement to Doxylamine succinate/Nov. 1974 |
| 040316 | Hoffman-LaRoche | Phenindamine (thephorin) |
| 040317 | Schiffman | Asthmador |
| 040318 | AMHO/Wyeth | Promethazine for allergy and in combo with Antitussive |
| 040319 | Wyeth Labs. | Promethazine adverse Reactions |
| 040320 | Parke-Davis | Benadryl/Antitussive |
| 040321 | Parke-Davis | Benadryl/Antitussive Appendix A |
| 040322 | Vick Division Research | Supplement to Vick Inhaler |
|
040323A 040323B |
FDA FDA |
Desi Reports Desi Reports |
| 040324 | Wyeth Labs. | Effectiveness of Promethazine |
| 040325 | FDA |
Epidemiology Antihistamine Toxline Search |
| 040326 |
Parke-Davis L. M. Lueck |
Benylin Cough Syrup (Benylin Expectorant) |
| 040327 | UpJohn Co. | Bronchodilators in Cough/Nadel |
| 040328 | A. H. Robins | Brompheniramine maleate |
| 040329 | Vick Division Research | Antitussive, Analgesic-Antipyretic and Decongestant |
| 040330 | Vick Division Research | Supplement to Vicks Nyquil submission |
| 040331 |
Wyeth Labs. Daniel L. Shaw |
Promethazine hydrochloride (Phenergan) |
| 040332 |
Smith Kline & French Cheston Simmons |
Summary of data to support the drying action of antihistamines when prescribed for acute coryza (common cold) for relieve of CCABA Panel |
| 040333 |
Warner-Lambert Co. Richard C. Brogle |
Thonzylamine (Neohetramine) and Phenyltoloxamine |
| 040334 |
Warner-Lambert Co. Richard C. Brogle |
Warner Lambert Co. Products |
| 040335 | Vick Division Research | Comments concerning dosage of specified dosage forms |
| 040336 | Vick Division Research | Self-medication |
| 040337 |
Ciba-Geigy Edward C. McKeon |
Nasal decongestants Naphazoline & Xylometazoline |
| 040338 | NCI Study on Chloroform | Report on Carcinogenicity |
| 040339 | Fisons Corp. | Antitussives (noscapine) |
| 040340 | Parke-Davis | Diphenhydramine |
| 040341 | Parke-Davis | Diphenhydramine |
| 040342 | Vick Chemical | Statement on DTC Cough/Colds principles applicable to combo. drugs |
| Top |
TFM VOLUME: 04BTFM
Has been established for Bronchodilator
Drug Products
TFM VOLUME: 04CTFM
Has been established for Anticholinergia
Drug Products
TFM VOLUME: 04HTFM
Has been established for Antihistamine
Drug Products TFM VOLUME: 04NTFM
Has been established for Nasal Decongestant Drug Products
